Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00937833
First received: July 10, 2009
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.


Condition Intervention
Urinary Incontinence
Prostate Cancer
Device: Surgisis Male Sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Incontinence score post prostatectomy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: November 2009
Estimated Study Completion Date: July 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Urethrovesical Sling Device: Surgisis Male Sling
The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
Other Name: SurgiSIS Biodesign
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have organ confined prostate cancer.
  • Patients must have PSA< 15.
  • Patients must have clinical stage prostate cancer < cT3.
  • Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
  • Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
  • Patients must be > 18 years of age.

Exclusion Criteria:

  • Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
  • Patients must not have a prostate size >100 cc as measured on digital rectal examination or transrectal ultrasound.
  • Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
  • Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
  • Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
  • Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
  • Patients must not have a prior history of radiation to the pelvis.
  • Patients must not have persistent bacteriuria that cannot be cleared by a negative urine culture within 1 month of surgery.
  • Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00937833

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Texas
Urology of San Antonio Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Chandru Sundaram, MD Indiana Cancer Pavilion
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00937833     History of Changes
Other Study ID Numbers: 08-015, 350017
Study First Received: July 10, 2009
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
prostate cancer
prostatectomy
incontinence

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Incontinence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014